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EC number: 257-104-6 | CAS number: 51277-96-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- February 24, 1987
- Deviations:
- yes
- Remarks:
- observation time only 7 d, thus, reversibility cannot finally be judged / test substance was used as 30% solution
- GLP compliance:
- yes
Test material
- Reference substance name:
- (hexadecylamidopropyl)trimethylammonium chloride
- EC Number:
- 257-104-6
- EC Name:
- (hexadecylamidopropyl)trimethylammonium chloride
- Cas Number:
- 51277-96-4
- Molecular formula:
- C22H47N2O.Cl
- IUPAC Name:
- (3-hexadecanamidopropyl)trimethylazanium chloride
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- water
- Test material form:
- solid - liquid: aqueous solution
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Age at study initiation: young adult- Weight at study initiation: Males: 2.175-2.500 kg; Females: 2.250-2.650 kg- Housing: individually in suspended wire bottom stainless steel cages- Diet (e.g. ad libitum): PM1 Rabbit Diet #5321; presented in measured amounts- Water (e.g. ad libitum): municipal water supply, ad libitum- Acclimation period: 5 dENVIRONMENTAL CONDITIONS- Temperature (°C): 72 ± 5°F (= 22°C)- Humidity (%): 30 - 80- Air changes (per hr): 10 - 12- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated left eyes served as controls.
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.1 mL
- Duration of treatment / exposure:
- 3 animals: treated eyes were washed after 30 s, 6 animals: treated eyes were washed after 24 h
- Observation period (in vivo):
- 7 d (the study was terminated on Day 7)
- Number of animals or in vitro replicates:
- 9 (3 washed after 30 s, 6 washed after 24 h)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE- Washing (if done): Three of the treated eyes (“washed eyes”) were each washed with room temperature deionized water for one minute beginning 30 seconds after treatment. All treated eyes were washed with room temperature deionized water for one minute immediately after recording the 24-hour observation.SCORING SYSTEM: Kay & Calandra ScaleTOOL USED TO ASSESS SCORE: white room lighting (daylight-type fluorescent tubes) + additional source of white light / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 d
- Remarks on result:
- positive indication of irritation
- Remarks:
- eyes washed after 24 h; 24 h unable to score due to severity of chemosis
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 d
- Remarks on result:
- positive indication of irritation
- Remarks:
- eyes washed after 24 h;24 h unable to score due to severity of chemosis
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 d
- Remarks on result:
- positive indication of irritation
- Remarks:
- eyes washed after 24 h; 24 h unable to score due to severity of chemosis
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 d
- Remarks on result:
- positive indication of irritation
- Remarks:
- eyes washed after 24 h; 24 h unable to score due to severity of chemosis
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: eyes washed after 24 h; 24 h unable to score due to severity of chemosis
- Irritation parameter:
- iris score
- Basis:
- animal: #4
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 2
- Reversibility:
- fully reversible within: 4 d
- Remarks on result:
- other: eyes washed after 24 h; 24 h unable to score due to severity of chemosis; constricted pipils still present at day 7
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 d
- Remarks on result:
- other: eyes washed after 24 h; 24 h unable to score due to severity of chemosis
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 2
- Reversibility:
- fully reversible within: 4 d
- Remarks on result:
- other: eyes washed after 24 h; 24 h unable to score due to severity of chemosis
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- within 7 d
- Remarks on result:
- positive indication of irritation
- Remarks:
- eyes washed after 24 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- within 7 d
- Remarks on result:
- positive indication of irritation
- Remarks:
- eyes washed after 24 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- within 7 d
- Remarks on result:
- positive indication of irritation
- Remarks:
- eyes washed after 24 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- within 7 d
- Remarks on result:
- positive indication of irritation
- Remarks:
- eyes washed after 24 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 d
- Remarks on result:
- positive indication of irritation
- Remarks:
- eyes washed after 24 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 d
- Remarks on result:
- positive indication of irritation
- Remarks:
- eyes washed after 24 h
- Irritant / corrosive response data:
- Washing after 30 s: Fluorescein staining was observed in all three eyes at 24 hours after treatment and persisted in two eyes through Day 7 after treatment. Corneal opacity was not possible to score after 1 h in 2/3 animals due to severity of chemosis. A slight dulling of normal luster (graded as 0.5) was present in all 3 animals from 24 h after treatment to day 4 or 7, respectively, after treatment. In 1/3 animals corneal opacity, grade1 was observed on day 7. Iris scores were 1 in all three animals 1 h and 24 h after treatment, and zero thereafter. Constricted pupils were observed in 2/3 animals up to day 4. Conjunctial redness grade 2 was present in all three animals after 1 h, advancing to grade 3 in 2/3 animals after 24 h. Grade 1-2 conjunctival redness was observed after 48 h, 72 h and after 4 d, and was still present in 2/3 animals at the end of the observation period of 7 d.Grade 3 chemosis was observed in 3/3 animals at the 1 h observation, grade 2 chemosis in 3/3 animals at the 24 h observation, grade 1-2 chemosis was observed after 48 h, 72 h and after 4 d, and was still present in 2/3 animals at the end of the observation period of 7 d.Grade 3 discharge was present in 3/3 animals after 1 h, receding to grade 2 after 2 h and grade 1 thereafter. Slight discharge (grade 1) was still present on day 7 in 1/3 animals.Washing after 24 h: Fluorescein staining was observed in all six eyes at 48 hours after treatment and persisted in all six eyes through Day 7 after treatment.Corneal opacity and iris were not possible to score after 1 and 24 h in all 6 animals due to severity of chemosis. Corneal opacity, grade 1 (4/6 animals) and 2 (2/6 animals) was observed after 48 h. From day 3 to 7, corneal opacity grade 2 was present in 3/6 animals and grade 1 in 3/6 animals. Iris scores were 0 in all six animals 48 h after treatment, 1 at the 72 h observation in 3/6 animals and was still present (grade 1) in 1/6 animals after 7 d. Constricted pupils were observed in 5/6 animals at the 48 h observation, in 4/6 animals at the 72 h observation, in 3/6 animals on day 4 and was still present in 2/6 animals on day 7.Conjunctial redness grade 2 was present in all three animals after 1 h. Grade 2-3 conjunctival redness was present at the 24, 48, 72 and 4 d observations. Grade 2 conjunctival redness was still observed after 7 d in all six animals. Grade 3 chemosis was present in all six animals at the 1 h and 24 h observations, and in 1/6 animals at the 48 h observation. Grade 2 chemosis was present in 5/6 animals at the 48 h observation, and in all six animals at the 72 h and 4 d observation. Grade 1 (1/6 animals) – 2 (5/6 animals) chemosis was still present in all six animals at the end of the observation period of 7 d.Grade 1 – 3 discharge was observed throughout the study period and was still present at the end of the observation time in 5/6 animals.
Any other information on results incl. tables
Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Washed after 30 s
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Discharge
|
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
Max. score: 3 |
|
60 min |
+/f/f |
1/1/1 |
2/2/2 |
3/3/3 |
3/3/3 |
24 h |
+/+/+ |
1/1/1 |
2/3/3 |
2/2/2 |
2/2/2 |
48 h |
+/+/+ |
0c/0c0c/ |
1/1/2 |
1/2/1 |
1/1/1 |
72 h |
+/+/+ |
0c/0c/0 |
1/2/2 |
1/2/1 |
1/1/1 |
4 d |
+/+/+ |
0c/0c/0 |
1/2/2 |
1/2/1 |
0/1/1 |
7 d |
+/1e/0 |
0/0/0 |
1/2/0 |
1/2/0 |
0/1/0 |
Average 24h, 48h, 72h |
0.5/0.5/0.5 |
0.3/0.3/0.3 |
1.3/2/2.3 |
1.3/2/1.3 |
1.3/1.3/1.3 |
Washed after 24 h
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Discharge
|
Max. score: 4 |
Max.score: 2 |
Max. score: 3 |
Max. score: 4 |
Max. score: 3 |
|
60 min |
f/f/f/f/f/f |
f/f/f/f/f/f |
2/2/2/2/2/2 |
3/3/3/3/3/3 |
3/3/2/3/3/3 |
24 h |
f/f/f/f/f/f |
f/f/f/f/f/f |
3/3/2/3/3/3 |
3/3/3/3/3/3 |
2/3/2/3/3/3 |
48 h |
1/1/1/2/1/2 |
0/0c/0c/0c/0c/0c |
3/3/2/3/3/3 |
2/2/3/2/2/2 |
2/2/2/2/2/2 |
72 h |
1/1/1/2/2/2 |
0/0/0c/1c/1c/1c |
3/2/2/3/3/3 |
2/2/2/2/2/2 |
2/2/2/2/2/2 |
4 d |
1/1/1/2/2/2 |
0/0/0c/0c/0c/0 |
3/2/2/3/2/3 |
2/2/2/2/2/2 |
2/1/1/2/2/2 |
7 d |
1/1/1/2/2/2 |
0/0/0/0c/1c/0 |
2/2/2/2/2/2 |
2/2/1/2/2/2 |
2/1/0/2/2/2 |
Average 24h, 48h, 72h |
1/1/1/2/1.5/2 |
0/0/0/0.5/0.5/0.5 |
3/2.7/2/3/3/3 |
2.3/2.3/2.7/2.3/2.3/2.3 |
2/2.3/2/2.3/2.3/2.3 |
+Slight dulling of normal luster, scored as 0.5
f) unable to score due to severity of chemosis
c) constricted pupils
e) apparent invasion of cornea by blood vessels
Fluorescein staining:
Eyes washed after 30 s |
Eyes washed after 24 h
|
|
24 h |
D/D/C |
f/f/f/f/f/f |
48 h |
D/C/C |
D/D/D/D/D/D |
72 h |
D/C/B |
D/D/C/D/D/D |
4 d |
C/B/B |
C/C/B/C/C/C |
7 d |
B/B/0 |
C/B/A/C/C/B |
Area of cornea involved
No fluorescein staining: 0
One quarter (or less), but not zero: A
Greater than one quarter, but less than half: B
Greater than half, but less than three quarters: C
Greater than three quarters, up to whole area: D
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- In this study, C16 Alkylamidopropyltrimethylammonium Chloride has irreversible effects on the eyes (Category 1) based on the effects being not reversible at the end of the observation period of 7 d.
- Executive summary:
In a primary eye irritation study according to OECD guideline 405 (February 24, 1987) 0.1 mL of C16 Alkylamidopropyltrimethylammonium Chloride (30% a.i.) was instilled into the conjunctival sac of the right eye of 9 young adult New Zealand White rabbits. The untreated left eyes served as controls. In 3 animals, the treated eyes were rinsedwith room temperature deionized water for one minute beginning 30 seconds after treatment. In the remaining 6 animals, the treated eyes were rinsedwith room temperature deionized water for one minute immediately after recording the 24-hour observation.
Animals were then observed for 7 days. Irritation was scored by the method of Kay and Calandra.
Washing after 30 s:
Fluorescein staining was observed in all three eyes at 24 hours after treatment and persisted in two eyes through Day 7 after treatment.
Corneal opacity was not possible to score after 1 h in 2/3 animals due toseverity of chemosis.A slight dulling of normal luster (graded as 0.5) was present in all 3 animals from 24 h after treatment to day 4 or 7, respectively, after treatment. In 1/3 animals corneal opacity, grade1was observed on day 7.
Iris scores were 1 in all three animals 1 h and 24 h after treatment, and zero thereafter. Constricted pupils were observed in 2/3 animals up to day 4.
Conjunctial redness grade 2 was present in all three animals after 1 h, advancing to grade 3 in 2/3 animals after 24 h. Grade 1-2 conjunctival redness was observed after 48 h, 72 h and after 4 d, and was still present in 2/3 animals at the end of the observation period of 7 d.
Grade 3 chemosis was observed in 3/3 animals at the 1 h observation, grade 2 chemosis in 3/3 animals at the 24 h observation, grade 1-2 chemosis was observed after 48 h, 72 h and after 4 d, and was still present in 2/3 animals at the end of the observation period of 7 d.
Grade 3 discharge was present in 3/3 animals after 1 h, receding to grade 2 after 2 h and grade 1 thereafter. Slight discharge (grade 1) was still present on day 7 in 1/3 animals.
Score at time point / Reversibility
Cornea
Iris
Conjunctivae
Chemosis
Discharge
Max. score: 4
Max. score: 2
Max. score: 3
Max. score: 4
Max. score: 3
60 min
+/f/f
1/1/1
2/2/2
3/3/3
3/3/3
24 h
+/+/+
1/1/1
2/3/3
2/2/2
2/2/2
48 h
+/+/+
0c/0c0c/
1/1/2
1/2/1
1/1/1
72 h
+/+/+
0c/0c/0
1/2/2
1/2/1
1/1/1
4 d
+/+/+
0c/0c/0
1/2/2
1/2/1
0/1/1
7 d
+/1e/0
0/0/0
1/2/0
1/2/0
0/1/0
Average 24h, 48h, 72h
0.5/0.5/0.5
0.3/0.3/0.3
1.3/2/2.3
1.3/2/1.3
1.3/1.3/1.3
Washing after 24 h:
Fluorescein staining was observed in all six eyes at 48 hours after treatment and persisted in all six eyes through Day 7 after treatment.
Corneal opacity and iris were not possible to score after 1 and 24 h in all 6 animals due toseverity of chemosis.
Corneal opacity, grade 1 (4/6 animals) and 2 (2/6 animals) was observed after 48 h. From day 3 to 7, corneal opacity grade 2 was present in 3/6 animals and grade 1 in 3/6 animals.
Iris scores were 0 in all six animals 48 h after treatment, 1 at the 72 h observation in 3/6 animals and was still present (grade 1) in 1/6 animals after 7 d. Constricted pupils were observed in 5/6 animals at the 48 h observation, in 4/6 animals at the 72 h observation, in 3/6 animals on day 4 and was still present in 2/6 animals on day 7.
Conjunctial redness grade 2 was present in all three animals after 1 h. Grade 2-3 conjunctival redness was present at the 24, 48, 72 and 4 d observations. Grade 2 conjunctival redness was still observed after 7 d in all six animals.
Grade 3 chemosis was present in all six animals at the 1 h and 24 h observations, and in 1/6 animals at the 48 h observation.
Grade 2 chemosis was present in 5/6 animals at the 48 h observation, and in all six animals at the 72 h and 4 d observation. Grade 1 (1/6 animals) – 2 (5/6 animals) chemosis was still present in all six animals at the end of the observation period of 7 d.
Grade 1 – 3 discharge was observed throughout the study period and was still present at the end of the observation time in 5/6 animals.
Score at time point / Reversibility
Cornea
Iris
Conjunctivae
Chemosis
Discharge
Max. score: 4
Max.score: 2
Max. score: 3
Max. score: 4
Max. score: 3
60 min
f/f/f/f/f/f
f/f/f/f/f/f
2/2/2/2/2/2
3/3/3/3/3/3
3/3/2/3/3/3
24 h
f/f/f/f/f/f
f/f/f/f/f/f
3/3/2/3/3/3
3/3/3/3/3/3
2/3/2/3/3/3
48 h
1/1/1/2/1/2
0/0c/0c/0c/0c/0c
3/3/2/3/3/3
2/2/3/2/2/2
2/2/2/2/2/2
72 h
1/1/1/2/2/2
0/0/0c/1c/1c/1c
3/2/2/3/3/3
2/2/2/2/2/2
2/2/2/2/2/2
4 d
1/1/1/2/2/2
0/0/0c/0c/0c/0
3/2/2/3/2/3
2/2/2/2/2/2
2/1/1/2/2/2
7 d
1/1/1/2/2/2
0/0/0/0c/1c/0
2/2/2/2/2/2
2/2/1/2/2/2
2/1/0/2/2/2
Average 24h, 48h, 72h
1/1/1/2/1.5/2
0/0/0/0.5/0.5/0.5
3/2.7/2/3/3/3
2.3/2.3/2.7/2.3/2.3/2.3
2/2.3/2/2.3/2.3/2.3
Reversibility cannot finally be judged as thestudy was terminated on day 7.
Thus, C16 Alkylamidopropyltrimethylammonium Chloride (30% a.i.), produced irreversible effects to the eye in this study and thus has to be classified as Category 1 (irreversible effects on the eye).
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